High Court Leaves Diabetes Drug Case Intact

The U.S. Supreme Court has refused to say that federal regulations preempted a Michigan law that was based on fraud. The High Court left intact a ruling favoring people who sued a pharmaceutical company after being harmed by Rezulin, a drug to combat diabetes. The dispute arose from several suits over Rezulin against Warner-Lambert, which is now owned by Pfizer. The court split 4-4 in the case, with Chief Justice John Roberts not participating because of a conflict of interest. The users of the drug were relying on a Michigan law, alleging that the pharmaceutical company engaged in fraud by misleading federal regulators in order to get the drug approved. Interestingly, the Michigan law shields pharmaceutical companies from product liability lawsuits unless they committed fraud. The question before the Supreme Court was whether the fraud exception, which allows lawsuits to proceed, is preempted by federal regulation of the pharmaceutical industry.

The U.S. Court of Appeals for the Second Circuit in New York ruled that the exception to the Michigan law was not preempted by federal regulations, allowing the plaintiffs to pursue the case. In the case, twenty-seven Michigan residents contended they suffered personal injuries caused by Rezulin. This is a drug that federal regulators approved despite risks to the liver and cardiovascular system. When you consider how weak and ineffective the FDA has been over the years, it’s inconceivable that federal preemption would be recognized simply because that agency approved a drug. All you have to do is count the number of drugs approved by the FDA and later recalled

because they were unsafe and dangerous. Vioxx is a classic example of how inept and ineffective the FDA really is, but there are many more such examples. Although this decision is a victory for consumers, it’s really not that significant in the larger scheme of things. Had the Chief Justice participated, the Court’s ruling could have gone the other way. The fight over preemption will continue in both the courts and in Congress. Without a doubt, it’s one of the most important battles for consumers in years and one that consumers can’t afford to lose.